Tislelizumab to treat classical Hodgkin’s lymphoma in ChinaMarch 6, 2020
BeiGene announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies.
The new drug application (NDA) was previously granted priority review by the NMPA, following the recent approval of zanubrutinib by the US FDA.
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc gamma receptors, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells.
The NMPA approval is based on the clinical results from a single-arm, multi-centre, pivotal phase 2 trial BGB-A317-203. Among the patients who were evaluable for responses, with a minimum follow-up of 12 months and a median follow-up of 14 months, the independent review committee (IRC)-assessed objective response rate (ORR) was 76.9% and the complete response (CR) rate was 61.5%.